CELESTODERM WITH GARAMICIN CREAM 15G

Trade name of the drug

Celestoderm-AT® with Garamicin®

International non-proprietary name or group name

Betamethasone + Gentamicin.

Dosage Form

Cream for external use.

Composition

1 g of cream contains

active ingredients: betamethasone 17-valerate 1.22 mg (equivalent to 1.0 mg betamethasone), gentamicin sulfate (equivalent to 1.0 mg (1000 IU) gentamicin);

excipients: white soft paraffin 150.0 mg, cetostearyl alcohol 72.0 mg, liquid paraffin 60.0 mg, macrogol-cetostearyl ester 22.5 mg, phosphoric acid 0.02 mg, sodium dihydrogen phosphate dihydrate 3.39 mg (equivalent to 3.0 mg of sodium dihydrogen phosphate monohydrate), chlorocresol 1.0 mg, sodium hydroxide and phosphoric acid (to establish the pH), purified water qs up to 1.0 g

Description

Uniform cream of white color of a soft consistence, not containing foreign inclusions.

Pharmacotherapeutic group

Antibiotic aminoglycoside + glucocorticosteroid.

Pharmacological properties

Celestoderm-B cream with Garamicin contains glucocorticosteroid (GCS) betamethasone valerate, which has anti-inflammatory, antipruritic and vasoconstrictor effects, and the antibiotic gentamicin, which has a broad spectrum antibacterial activity.Gentamicin-susceptible bacteria includes susceptible strains of Staphylococcus aureus (coagula-ixi-oi), coagulase-negative and some penicillinase-producing strains, as well as Gram-negative bacteria Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia iheri, pi, antiheroniasis, Aerobacter aerogenes, Escherichia, and A-phytocytosis, as well as Gram-negative bacteria Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia, and Ausobiterus, have anti-genes, and Gram-negative bacteria.

Indications for use

Local treatment of skin diseases susceptible to corticosteroids, in the presence of a secondary infection caused by susceptible gentamicin microorganisms, or if such an infection is suspected: eczema (atopic, pediatric, monomatous), contact dermatitis, seborrheic dermatitis, neurodermatitis, solar dermatitis, exfoliative dermatitis, radiation dermatitis, diaper rash, psoriasis, anogenital and senile itching.

The cream is used for diseases of wet or oily skin.

Contraindications

Hypersensitivity to any of the components of the drug.

Skin tuberculosis, skin manifestations of syphilis, chicken pox, herpes simplex, fungal skin diseases.

Vaccination period and skin vaccine reactions.

Lactation period.

Pregnancy (long-term treatment of large areas of skin).

Children age - up to 6 months.

Carefully

Pregnancy (in the absence of criteria for contraindication) - especially in the 1st trimester;

Long-term treatment of large areas of skin, especially in children, or in the presence of cracked skin or the use of occlusive dressings.

Dosage and administration

Outwardly.

Apply a thin layer of cream on the affected skin 2 times a day - in the morning and evening.

The required frequency of application should be determined by the doctor, focusing on the severity of the disease. In mild cases, once-daily application is usually sufficient, with more severe lesions, more frequent use may be required. The duration of treatment depends on the severity, location of the lesion and the patient's response to treatment.

Side effect

When applying the cream Celestoderm-B with Garamycin, hypersensitivity reactions, rashes and skin pigmentation disorders are encountered.

The following local reactions are possible due to the use of betamethasone, especially when using occlusive dressings: skin irritation (itching, erythema), burning sensation, dry skin, folliculitis, hypertrichosis, steroid acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, stria, prickly heat.

When treating gentamicin, transient irritation of the skin (erythema, pruritus) occurs, usually not requiring discontinuation of treatment.

With prolonged treatment or application to a large surface, the systemic side effects typical for SCS can be developed: weight gain, osteoporosis, high blood pressure, edema, ulceration of the mucous membrane of the gastrointestinal tract, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, impaired menstrual cycle.

In children, in addition, the following side effects may occur,caused by the use of betamethasone: suppression of the function of the hypothalamic-pituitary-adrenal system, Itsenko-Cushing syndrome, growth retardation, lag in weight gain, increase in intracranial pressure. Symptoms of inhibition of adrenal cortex function in children include a decrease in plasma cortisol concentration and a lack of response to the stimulation of adrenocorticotropic hormone (ACTH). Increased intracranial pressure is manifested by bulging of the fontanel, headache, bilateral swelling of the optic nerve head.

Overdose

Symptoms Excessive or prolonged use of local corticosteroids or use in doses exceeding those recommended may cause inhibition of the function of the pituitary-adrenal system, which may cause the development of secondary insufficiency of the adrenal cortex and the emergence of symptoms of hypercorticism, including Itsenko-Cushing syndrome.

A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Prolonged use or use in doses exceeding the recommended, can lead to a significant increase in insensitive microflora, including fungal, in the lesion.

Treatment. Corresponding symptomatic treatment is indicated. The acute symptoms of hypercorticism are usually reversible. If necessary, a correction of the electrolyte balance is shown. In the case of chronic toxic effects, the gradual abolition of corticosteroids is recommended.

If uncontrolled growth of insensitive microorganisms or the development of a fungal infection is uncontrolled, treatment should be stopped and appropriate therapy should be selected.

Interaction with other drugs

No interaction of Celestoderm-B with Garamicin with other drugs has been registered.

special instructions

In the absence of the effect of treatment within two weeks, it is recommended to contact your doctor for further diagnosis and treatment.

If the use of the drug marked irritation or hypersensitivity, treatment should be stopped and the patient should choose a different therapy.

Any side effects of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed when using local HSCs, especially in children. Systemic absorption of local corticosteroids may increase with prolonged use, treatment of large areas of the body, or the use of occlusive dressings. In such cases, especially in children, appropriate precautions should be observed, including the possibility of discontinuation of the drug, determined by the doctor depending on the severity of the disease.

Systemic absorption of gentamicin when applied topically may increase if applied to large areas of the skin, especially with prolonged treatment or in the presence of cracked skin. In such cases, the development of adverse events characteristic of gentamicin in its systemic use is possible (seesection "Side Effects"), therefore caution is recommended, especially in children, which requires the doctor to determine the frequency of use and the duration of therapy.

Cross allergic reactions to aminoglycoside antibiotics were observed.

With prolonged topical administration of gentamicin, the growth of insensitive microflora, including fungal, can be occasionally observed. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, the treatment must be stopped and appropriate therapy prescribed.

Celestoderm-B Cream with Garamicin is indicated only for external use and is not intended for use in ophthalmology.

Pediatric use

Celestoderm-B cream with Garamicin can be used to treat children from the age of 6 months.

Children may be more susceptible to the action of local corticosteroids, causing depression of the hypothalamic-pituitary-adrenal system, than older patients. This is due to the higher absorption of the drug in children due to the greater value of the ratio of surface area and body weight.

Use during pregnancy and lactation

Due to the fact that the safety of using local corticosteroids in pregnant women has not been established, the prescription of drugs of this class during pregnancy is justified only if the benefit to the mother clearly exceeds the possible harm to the fetus. HSC should not be used during pregnancy for a long time or in large doses.

Since it has not yet been established whether HSC, when applied topically and with the absorption system, can penetrate into breast milk, a decision should be made to discontinue breastfeeding or discontinue the drug, considering how necessary it is for the mother.

Influence on ability to drive vehicles and work with mechanisms

No effect of Celestoderm-B with Garamicin on the ability to drive and operate machinery was detected.

Release form

Cream for external use of 0.1% + 0.1%. 15 g or 30 g in an aluminum tube coated with epoxy lacquer and a closing membrane and a screw cap. On one tuba together with the application instruction in a cardboard pack.

Shelf life

3 years. Do not use the drug after the expiration date.

Storage conditions

In the reach of children.

Store at a temperature not higher than 25 ºС.

Vacation conditions

On prescription.